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C. Difficile Toxin Antitoxin Kit

FDA UDI

Class I (US FDA UDI)

by Techlab, Inc.

Identity

Trade Name
C. DIFFICILE TOXIN ANTITOXIN KIT FDA UDI
Generic Name
Clostridium difficile antigen IVD, kit, cell culture assay FDA UDI
Device Name
The Clostridium difficile Toxin/Antitoxin Kit is intended for use in conjunction with the tissue culture cytotoxicity assay for the confirmation of Clostridium difficile toxin in patient specimens. The kit includes a toxin control reagent and a specific C. difficile antitoxin for use in a tissue culture assay. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. FDA UDI
Model / Reference
T5000 FDA UDI
Description
The Clostridium difficile Toxin/Antitoxin Kit is intended for use in conjunction with the tissue culture cytotoxicity assay for the confirmation of Clostridium difficile toxin in patient specimens. The kit includes a toxin control reagent and a specific C. difficile antitoxin for use in a tissue culture assay. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. FDA UDI

Identifiers

Primary DI / UDI-DI
00857031002066 FDA UDI
510(k) Number
K923463 FDA UDI
FDA Product Code
LLH FDA UDI
GMDN Term
Clostridium difficile antigen IVD, kit, cell culture assay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Clostridium difficile antigen IVD, kit, cell culture assay

C. Difficile Toxin Antitoxin Kit by Techlab, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Clostridium difficile antigen IVD, kit, cell culture assay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Techlab, Inc.

Sources (1)

  • FDA UDI 9c3ef5f9-0d22-4dfd-86f2-a548247c03c0 34 fields · synced May 30, 2026